A Pilot One and Two-Year Prospective, Blinded Clinical Evaluation of Efficacy, and Safety of Combined Treatment With Crosslinked Hyaluronic Acid Dermal Filler and Barbed Polydioxanone Suspension Threads for Mid-Face Contour Enhancement.

[INTRODUCTION] The combination of hyaluronic acid (HA) fillers and polydioxanone (PDO) thread lifting is gaining popularity for mid-face rejuvenation, especially among the Asian population. Despite the common use of these techniques, there is a paucity of long-term studies assessing their combined efficacy and safety. This study aims to evaluate the efficacy and safety of combined HA filler and PDO thread treatment for mid-face rejuvenation over a 24-month period in a Korean population.

[MATERIALS AND METHODS] This prospective, blinded, single-center, open-label trial included 11 Korean subjects, aged 29-70 years, with mid-face volume loss graded 1-4 on the antero-medial cheek fullness scale. Participants were treated with crosslinked HA dermal fillers and PDO threads. Assessments were conducted using the Global Aesthetic Improvement Scale (GAIS), investigator-led clinical evaluations, and volumetric measurements using the Morpheus 3D system at baseline, 6, 12, and 24 months post-treatment.

[RESULTS] Quantitative analysis revealed a significant reduction in mid-face width from an average baseline of 149.27-145.00 mm at 24 months (p < 0.00001). Similarly, lower-face width decreased from 130.36 to 117.27 mm at 24 months (p < 0.00001). The GAIS scores demonstrated high levels of subject satisfaction, with 9 out of 11 patients reporting consistent satisfaction or improvement over 24 months. Minimal adverse events were reported, and no serious complications occurred.

[DISCUSSION] The combination of HA fillers and PDO threads was effective in achieving and maintaining long-term improvements in facial volume and contour. The Morpheus 3D system provided objective volumetric data, which supported the subjective improvements observed by patients and investigators. The study results highlight the benefits of ongoing neocollagenesis and tissue remodeling beyond the dissolution period of the materials.

[CONCLUSION] The combination of HA filler injections and PDO thread lifting offers a promising and minimally invasive option for long-term mid-face rejuvenation with high patient satisfaction and a favorable safety profile. Further studies are warranted to confirm these findings across diverse populations and compare this approach with other aesthetic treatments.